EU Drug Regulator to Recall Some Batches of Astellas’s Advagraf
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The European Medicines Agency said it agreed to a precautionary recall of some batches of Astellas Pharma Inc.’s Advagraf after detection of more active substance than expected being released from the capsules.
The batches of 0.5-milligram capsules will be recalled from pharmacies and wholesalers across the European Union, the agency said today in a statement on its website. There is nothing to suggest that the defect in the capsules is linked to adverse effects in patients, the EMA said.